Safety verification study of the new peripheral intravenous catheter

Not Applicable

• Conditions: Which are needed administrations of stimulating drugs (excluding anticancer drugs)

• Registration Number: JPRN-jRCTs032200076
• Lead Sponsor: Kurokawa Mineo

Brief Summary

When a new catheter was indwelled in the upper arm vein for infusion, no adverse event occurred. In some cases, temporary occlusion alarm of the infusion pump was encountered. However, the frequency was not high considering the frequency of catheter failure in commonly used catheters, and treatment was not interrupted. Therefore, it was confirmed that the new catheter could be used safely by examining the cause of the malfunction that occurred during this investigation and taking countermeasures.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-03
• Study Completion: 2020-12-18
• Results First Posted: 2021-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1)Who are scheduled to administrate stimulating drugs* (excluding anticancer drugs) using PIVC. (*Cytotoxic agents, Vesicant solutions, Irritant solutions, Hyperosmotic agents)
2)Over 19 years, regardless of gender
3)Who can expect continuous infusion therapy over 24 hours
4)Who have obtained their own written consent

Exclusion Criteria

1)Who are unable to maintain the position to fully rotate the shoulder joint and rotate the elbow joint
2)With skin disorders at the puncture site
3)With peripheral neuropathy
4)With a history of vasovagal reflex due to puncture
5)With a history of thrombosis
6)With end-stage renal disease (stage II or higher)
7)With abnormal blood coagulation or bleeding tendency (PT-INR 1.5 or more, APTT 36.1 seconds or more, while taking any anticoagulant or antiplatelet drug)
8)Who is planned of highly invasive tests (endoscopy, bronchoscopy)
9)Whose physician judges that participation in this study is inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nexpected device malfunctions and adverse events up to 7 days after placement of the new peripheral intravenous catheter, and Incidence of adverse events up to 24 hours after removal.

Secondary Outcome Measures

Name	Time	Method
1)Success rate of catheter placement<br>2)The incidence of Catheter failure<br>3)Subjective evaluation of catheter placement in patients